1. Field of the Invention
This invention relates to a novel method of reducing the appearance of rhytides (“facial wrinkles”) and/or infra-orbital shadows (“dark circles”) under the eyes, and striae (“stretch marks”), lentigo senilis (“age spots”), and hyper/hypo pigmentation on other anatomical areas. Particularly, this invention relates to a topical patch worn on the skin that in a preferred embodiment incorporates two distinct layers, each providing useful features and together providing a novel article and method for improving skin cosmesis. Ease of use, patient comfort and cost effectiveness are provided.
2. Description of the Prior Art
Wrinkles occur on the face as a result of several factors including the gradual loss of skin elasticity, the long-term effects of gravity, exposure to ultraviolet radiation from the sun as well as the natural process of losing fat tissue in certain areas of the face as one ages. Cosmetic makeup or surgical interventions are often used to reduce the appearance or presence of facial wrinkles. Depending on the severity of the condition and the patient's motivation for remedy, there exists a wide variety of treatment options. Protocols range from simple topical applications to invasive surgery.
The appearance of superficial fine lines can be easily reduced with ordinary cosmetic makeup available in a wide range of formats and presentations. Topical applications have also been used to reduce the appearance of fine wrinkles by delivering active ingredients such as antioxidants, vitamins and other agents to the skin. As one escalates up the severity/motivational scale, chemical peels using agents such as phynel, trichloroacetic acid or alphahydroxy acid become an option. These techniques do have a rejuvenating effect on the skin, but are painful and may cause a significant period of erythema and/or edema after the procedure. In addition, chemical peels can present a risk of scarring due to excessive depth of penetration.
Another method of reducing facial wrinkles is soft-tissue augmentation using a cannula to implant either natural tissue or a synthetic biomaterial under the skin. Volume is thus added to the underlying tissue thereby reducing sagging and wrinkles of the overlying skin. Autologous tissue, collagen from allogeneic or xenogeneic sources, expanded polytetrafluoroethylene and a broad range of other materials have been used for this purpose.
More drastic means of alleviating facial wrinkles include surgical rhytidectomy or “face-lift,” where the patient's skin is lifted from the underlying tissue and retracted. The excess skin is then trimmed and the remaining skin is anchored in a tightened position using sutures.
Botulinum toxin is an additional technique that is commonly used for the reduction of facial wrinkles. Botox® (Allergan, Inc. Irvine, Calif.) is a purified protein produced by the clostridium botulinum bacterium. Botox reduces the activity of the muscles that cause wrinkles and “frown lines” when injected. While this procedure has become widely practiced it is nonetheless invasive, painful and requires periodic re-treatments. Because it essentially paralyses the underlying musculature, a “frozen expression” effect is sometimes experienced.
Frownies® (B&P Company Dayton, Ohio) are described by the marketer as “facial pads made from natural, skin-friendly materials. Frownies are applied to the forehead and corners of the eyes and mouth to gently re-educate the underlying muscles to assume their correct, relaxed and natural appearance. Frownies, in fact, allow the deep expression lines to heal leaving younger, relaxed-looking skin.” The product is promoted as a “Botox Alternative.” The Company claims “results were achieved after using Frownies every night for only 3 weeks.”
In recent years laser resurfacing and rejuvenation techniques have emerged. Ablative techniques are used to remove the epidermis and a precisely controlled amount of the dermis, thereby removing sun damaged skin and providing a rejuvenating effect as the skin heals and the native collagen remodels. My U.S. Pat. No. 4,832,009, which is incorporated herein by reference, describes a dressing comprising a semi-interpenetrating polymer network of polytetrafluoroethylene and silicone, which is commonly used as a temporary skin replacement for such laser inflicted wounds. (Suarez, et. al., A novel dressing for skin resurfacing. Dermatol Surg 1998; 24:567-570)
My U.S. Pat. Nos. 5,656,279, 5,759,560, 5,980,923 and 7,087,135, all of which are incorporated herein by reference, describe silicone-based scar management products that are used for reducing and preventing scars subsequent to dermal injury and methods of their manufacture. These products are believed to work by hydration, wherein the silicone material provides moisturizing effect that reduces the tendency for scar formation or reduces an existing scar by accelerating the collagen remodeling process. (Chang, C C, et. al., Hydration, not silicone, modulates the effects of keratinocytes on fibroblasts. J Surg Res 1995; 59:705-11)